Therapeutic Goods Administration

Site

Laboratories Branch Biotherapeutics

Accreditation No.

2432

Site No.

2665

Date of Accreditation

30 Jun 1989

Address

1 Tindal Lane
Canberra Airport, ACT 2609
Australia

tga.gov.au

Contact

Ms Erin Fitzgerald P: +61 (02) 62894107

Availability

Services conditionally available to external clients

Therapeutic Goods Administration address map

Scope of Accreditation

Print scopes

Withdrawn 18 Feb 2025

Voluntary

Laboratories Branch Biotherapeutics

ISO/IEC 17025 (2017)

Healthcare, Pharmaceutical and Media Products

Withdrawn
Service Product Determinant Technique Procedure
Biological analysis of human and veterinary medicines including vaccines Anti-coagulants; Blood products; Cytokines; Enzymes; Heparin; Hormones; Monoclonal antibodies; Plasma products Content; Identity; Potency Chromatography; Coagulation; Electrophoresis; Enzyme activity; Enzyme linked immunosorbent assay (ELISA); Mass spectrometry (MS)

By the methods in capillary electrophoresis manual, electrophoresis manual, enzyme activity manual, general laboratory methods manual, HPLC manual, Sysmex manual

Biological medicines; Vaccines Content; Identity; Potency; Purity Cell culture; Chromatography; Coagulation; Electrophoresis; Enzyme activity; Enzyme linked immunosorbent assay (ELISA); Immunodiffusion; Mass spectrometry (MS); Polymerase chain reaction (PCR)

By BP, PhEur, USP, manufacturer and in-house methods for Capillary electrophoresis, Cell culture, Electrophoresis, ELISA,  Enzyme activity, General laboratory procedures, HPLC, Influenza, PCR and Sysmex

Pharmaceuticals LAL bacterial endotoxin Limulus amoebocyte lysate (LAL)

By BP, PhEur, USP, manufacturer and in-house methods for Bacterial Endotoxin

The only data displayed is that deemed relevant and necessary for the clear description of the activities and services covered by the scope of accreditation.

Grey text appearing in a SoA is additional freetext providing further refinement or information on the data in the preceding line entry.